FDA Withdraws 1977 Hearing Notices for Antimicrobials

December 28, 2011 —

The Food and Drug Administration (FDA) is withdrawing two 1977 notices of opportunity for a hearing (NOOH), which proposed to withdraw certain approved uses of penicillin and tetracyclines intended for use in feeds for food-producing animals based in part on microbial food safety concerns. FDA is taking this action, and closing the corresponding dockets, because: FDA is engaging in other ongoing regulatory strategies developed since the publication of the 1977 NOOHs with respect to addressing microbial food safety issues; FDA would update the NOOHs to reflect current data, information, and policies if, in the future, it decides to move forward with withdrawal of the approved uses of the new animal drugs described in the NOOHs; and FDA would need to prioritize any withdrawal proceedings (for example, take into account which withdrawal(s) would likely have the most significant impact on the public health) if, in the future, it decides to seek withdrawal of the approved uses of any new animal drug or class of drugs.

In 1977, FDA published two NOOHs in the Federal Register on proposals by the Bureau of Veterinary Medicine (now Center for Veterinary Medicine) to withdraw all uses of penicillin in animal feed, and all subtherapeutic uses of tetracycline in animal feed except for a couple of specific uses involving oxytetracycline and chlortetracycline.

At the same time, FDA also published two companion proposed rules proposing to amend the regulations to delete those provisions referencing the approved penicillin and tetracycline uses that would be affected by a withdrawal. FDA did not withdraw any approved use of penicillin or tetracyclines intended for use in feeds for food-producing animals as a result of these NOOHs, or finalize the proposed companion rules, and some new animal drug approvals for the use of these new animal drugs in feeds for food-producing animals remain in effect. Although FDA initially granted some hearing requests to provide sponsors with the opportunity to present evidence on the safety of the NOOH products, Congress intervened before any hearing was held, directing FDA to hold in abeyance the implementation of its proposed withdrawal actions pending the outcome of further research related to the use of antibiotics in animal feed.

Although FDA is withdrawing the 1977 NOOHs, FDA continues to view antimicrobial resistance as a significant public health issue. Today’s action should not be interpreted as a sign that FDA no longer has safety concerns about the use of medically important antibiotics in food producing animals or that FDA will not consider re-proposing withdrawal proceedings in the future, if necessary. FDA has not ruled out the prospect of future regulatory action, either with respect to the antimicrobial new animal drugs covered by the 1977 NOOHs or any others. However, for now, FDA’s efforts will focus on promoting voluntary reform and the judicious use of antimicrobials in the interest of best using the agency’s overall resources to protect the public health. Importantly, this strategy leaves open the possibility of pursuing withdrawal proceedings at a later time if FDA’s proposed strategy does not yield satisfactory results.